Unresolved myofascial injuries represent the second largest medical problem today, with back pain alone accounting for the largest medical visits. Carpal tunnel syndrome (CTS), repetitive stress injuries (RSI) account for the most days lost and are predicted to become the most costly health problem of our time. With the implementation of the American's with disability (ADA) law worker's compensation claims such as CIS can now sue in the federal court system allowing for the initiation of suits in excess of 10 million dollars. These claims could damage the economy and force employers to go outside of the United States.
A recent study in the New England Journal of Medicine indicates that over 58% of asymptomatic low back pain patients who underwent an MRI found evidence of disc pathology. How reliable is an MRI--it appears to have no correlation to pain, impairment and may not be clinically significant.
A recent study revealed that over 45 percent of individuals who have undergone CTS release surgery were no better two years past the surgical intervention because they were misdiagnosed. The individuals probably had cervical pathology that can refer pain and mimic the symptoms of carpal tunnel, ulnar neuopathy, cubital tunnel, tendonititis, DeQuarians syndrome i.e., repetitive stress injuries. The problem is that until the development of the instant invention, there was no way to ascertain if the problem was proximal (cervical or distal CTS).
In the past, many doctors have prescribed a profilastic work restriction limiting the amount an individual can lift. More often than not, the lifting restriction is too general and too limiting which prohibits the individual to return back to their usual and customary job. For example, a typical work restriction of no lifting over 50 pounds is highly restrictive. Doctors impose this restriction because they have no means of evaluating the muscle and disc pathology during movement.
The inventive integrated movement analyzer (IMA) is a portable, non-loading electronic instrument that simultaneously monitors muscle activity with silver chloride standard ECG electrodes, cervical, thoracic and lumbar flexion, extension, right rotation, left rotation, right lateral movement, and left lateral movement. The IMA also simultaneously combines a non loading load cell and strain gauge that with a computer and software correlates the weight lifted by pulling on the strain gage. The EMG, Range of Motion and FCE (functional capacity evaluation) are all conducted at the same time.
The IMA is portable and can be battery operated to allow the patient to be monitored anywhere including at the work sight, at home and performing any activity even their job, no matter what or where it is. The IMA also complies with the new ADA law, and includes a special device that allows for heart rate in the filter system. This is important because when heart rate is found in the paraspinal muscles over the EMG, in the upper trapezius and in the low back, the amplitude of the ECG activity that overlaps the EMG correlates to disc pathology or spinal changes on an MRI. Since the IMA monitors active range of motion, it takes the MRI one step further and can help determine if the monitored ailment, can in fact, be treated with conservative methods that do not involve surgery.
A search of the prior art did not disclose any patents that read directly on the claims of the instant invention. However, the following U.S. patents were considered related:
______________________________________ U.S. Pat. No. INVENTOR ISSUED ______________________________________ 5,042,505 Mayer et al 27 August 1991 4,688,581 Moss 25 August 1987 4,667,513 Konno 26 May 1987 ______________________________________
The U.S. Pat. No. 5,042,505 Mayer, et al patent discloses an electronic device for measuring relative angular positional displacement and angular range of motion for body segments and articulating joints of the human skeleton. The device has a hand-held interface unit which is placed against the body segment or joint to be tested. Mounted within the housing of the interface unit is a shaft with a pendulum at one end and an optical encoder at the other. As the body segment rotates or the joint articulates, the pendulum swings in the direction of gravity, causing the shaft to rotate. The optical encoder generates an electrical signal representative of the amount of rotation of the shaft. The generated signal is fed to a microprocessor which processes the information and can produce on a display the change in angular position relative to initial angular position or the angular range of motion of the body segment or articulating joint.
The U.S. Pat. No. 4,688,581 Moss patent discloses an apparatus and a method for non-invasive in vivo determination of muscle fiber composition. The method includes the steps of electrically stimulating a chosen muscle; determining the stimulation current; measuring the electrical potential of the muscle; the contraction time; and the force produced by the contraction; and by intercorrelating the data by multiple regression, determining the type, percentage and size of muscle fibers within the muscle stimulated. Apparatus for determining the muscle composition includes a muscle stimulator of controlled voltage; electromyogram equipment; and a force transducer providing a tension curve as well as force measurements.
The U.S. Pat. No. 4,667,513 Konno patent discloses an apparatus and a method for estimating the degree of the fatigue and pain of muscles. The apparatus composes subjects of different weights on the same basis by deriving the variation in the muscular strength such as the dorsal muscular strength, shoulder muscular strength, the grasping power, and the like. An analogous electric signal integrated the muscular output on one hand, and provides an integrated value of the electromyogrammatic amplitude by processing the voltage induced from the muscle to be tested through an electromyogram amplitude and a waveform processor. The ratio between these integrated values, after correcting the ratio with a weight/muscular strength coefficient is digitally displayed.
For background purposes and as indicative of the art to which the invention relates, reference may be made to the following remaining patents found in the search:
______________________________________ U.S. Pat. No. INVENTOR ISSUED ______________________________________ 5,056,530 Butler et al 15 October 1991 5,050,618 Larsen 24 September 1991 5,038,795 Roush, et al 13 August 1991 5,012,820 Meyer 7 May 1991 4,886,073 Dillon et al 12 December 1989 4,845,987 Kenneth 11 July 1989 4,834,057 McLeod, Jr. 30 May 1989 4,805,636 Barry et al 21 February 1989 4,742,832 Kauffmann et al 10 May 1988 ______________________________________